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Clinical Trial Details (PDF Generation Date :- Sat, 02 Oct 2021 01:52:47 GMT)

CTRI Number CTRI/2017/04/008288 [Registered on: 03/04/2017] - Trial Registered Prospectively Last Modified On 06/05/2019 Post Graduate Thesis No Type of Trial Interventional Type of Study Ayurveda Study Design Randomized, Parallel Group Trial Public Title of Study A study of the effect of an Ayurvedic formulation in patients with newly diagnosed Type 2 Diabetes melitus Scientific Title of A Multicenter, Open Label, Randomized, Parallel Group Clinical Study Designed To Examine The Study Efficacy And Safety Of TLY-001 In Both Kashayam And Kashayam Tablet Form Twice Daily Oral Dose In 150 Patients With Newly Diagnosed Type 2 Diabetes Mellitus Over A Period Of Ninety (90) Days. Secondary IDs if Any Secondary ID Identifier DAME-001 Version 01 dated 03 March 2017 Protocol Number Details of Principal Details of Principal Investigator Investigator or overall Name Dr Hariprasad P Trial Coordinator (multi-center study) Designation Overall Trial Co-ordinator Affiliation CARe-KERALAM Ltd Address Research & Development CARe-KERALAM Ltd. KINFRA Small Industries Park Nalukettu Road, Koratty Thrissur District, Kerala, India Thrissur KERALA 680309 India Phone 0480-2735737 Fax 0480-2735837 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Hariprasad P Query) Designation Overall Trial Co-ordinator Affiliation CARe-KERALAM Ltd Address Research & Development CARe-KERALAM Ltd. KINFRA Small Industries Park Nalukettu Road, Koratty Thrissur District, Kerala, India

KERALA 680309 India Phone 0480-2735737 Fax 0480-2735837 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Sreejith Sreekumar Designation Chief Executive Officer Affiliation Clinfound Clinical Research Services Pvt Ltd Address Chennal Buildings Kumaramangalam PO Thodupuzha Idukki dist Kerala India Idukki

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KERALA 685597 India Phone 04846007955 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > CARe-KERALAM Ltd.,KINFRA Small Industries Park Nalukettu Road, Koratty 680309 Thrissur District, Kerala, India Primary Sponsor Primary Sponsor Details Name Clinfound Clinical Research Services PvtLtd Address Chennal Buildings Kumaramangalam PO Thodupuzha,Kerala India 685597 Type of Sponsor Contract research organization Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Anil V Kaimal Aster AyurVAID Center Medical Superintendent 04846699999 for Integrated Medicine and Senior Physician 3rd Floor,Annexe [email protected] Building Aster Medicity,Kochi,682027 Ernakulam KERALA Dr Hariprasad P CAReKeralam Ltd KINFRA Small 0480-2735737 Industries Park 0480-2735837 Nalukettu Road, Koratty research@carekeralam. 680309 Thrissur com District, Kerala, India Thrissur KERALA Dr Basavaraj S Centre for Integrative Professor, Division of 08202922727 Hadapad Medicine and Ayurveda Centre for 0820-2570061 Research,Manipal Integrative Medicine [email protected] University and Research Manipal du University, Manipal – 576104, India Udupi KARNATAKA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional Ethics Submittted/Under No Date Specified No Committee Aster Review Medicity situated at KUTTISAHIB Road, near Kothad Bridge, South Chittoor P.O Cheranallor Kochi-682027 Kerala India Institutional Ethics Approved 05/02/2019 No

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Committee,Kasturba Hospital HR Department manipal-576104 India SMHRIndependent Approved 27/03/2017 No Ethics Committee,Kochi ,Kerala,682030 Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Type 2 diabetes mellitus without complications Intervention / Type Name Details Comparator Agent Intervention TLY-001 Kashayam 15 ml TLY-001 Kashayam to be taken along with 45ml luke warm water, twice daily morning 7 AM and evening 6 PM oral administration in empty stomach for 90 days after the enrolment. Comparator Agent TLY-001 Kashayam Tablet 2 TLY-001 Kashayam Tablet twice daily morning 7 AM and evening 6 PM oral administration in empty stomach for 90 days after the enrolment Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 70.00 Year(s) Gender Both Details 1.Patients with FBS ? 130 mg/dl to ? 250 mg/dl.
2.Patients with BMI ? 45 kg/m2 .
3.Newly detected Type 2 Diabetes Mellitus (not more than 1 year).
4.The patient with the ability to understand and provide written informed consent form, which must have been obtained prior to screening.
5.Patients willing to comply with protocol requirements
Exclusion Criteria Exclusion Criteria Details 1.Patients with Type 1 Diabetes or secondary form of Diabetes 2.Pregnant, breast feeding, or planning a pregnancy. 3.Patient with history of treatment with Insulin 4.Patient with history of treatment with any antihyperglycaemic agent. 5.Active, uncontrolled, or clinically significant diseases or disorders of the heart, lung, kidney, GI tract, or central nervous system. 6.Known to have AIDS or HIV positive.

Method of Generating Computer generated randomization Random Sequence Method of An Open list of random numbers Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints Fasting Blood Sugar and Post Prandial Blood Baseline,Day 30,Day 60,Day 90 Sugar Secondary Outcome Outcome Timepoints HbA1C Baseline and Day 90

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Lipid Profile Baseline and Day 90 Liver Function Test Baseline and Day 90 Renal Function Test Baseline and Day 90 Target Sample Size Total Sample Size=150 Sample Size from India=150 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial N/A Date of First 20/04/2017 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=1 Trial Months=0 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details No publications as of now Brief Summary TLY-001 was taken from palm leaf manuscript which is an Anti-diabetic formulation which was in practice long time ago. Due to improper documentation and subsequent transfer of formula to the next generation, the formula was remaining idle. The Traditional Knowledge Innovation-Kerala (TKIK) under the Directorate of Ayurveda Medical Education (DAME) identified the medicinal formulation TLY-001 for drug development and commercialisation to provide an effective medicine fo the suffering diabetic population. Acute toxicity study and Sub-chronic toxicity study of the formulation has been done and found non-toxic. Anti-diabetic study of the formulation showed effective in wistar albino rats. The compelling results of anti-diabetic efficacy of the formulation in wistar albino rats prompted a desire to translate these results systematically to humans. This multi-center, open label clinical trial will evaluate the anti-diabetic effect of TLY- 001 in patients with Type 2 Diabetes Mellitus

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